In the health-care industry, diagnostic testing of body fluids is a common place activity. Employers, government agencies, sports teams and other organizations have also become increasingly involved in diagnostic testing to maintain safety in the workplace and to ensure compliance with laws, rules and regulations.
It is generally necessary in diagnosing and testing for the presence of a predetermined analyte (e.g. drugs and/or disease) to collect biological fluids from an animal or human, i.e., urine, blood, sputum, pleural, cavity and peritoneal cavity fluids for analysis. Maintaining the integrity of the collected biological fluid specimens is vital to obtaining reliable test results and to preserving an uncontaminated sample for subsequent confirmatory testing. It is of utmost importance during the collection and handling of biological fluid specimens that the potential for specimen contamination be minimized or eliminated. It is also important to minimize the potential for specimen damage during the collection process and testing process.
Many known devices for collecting and testing body fluids involve multiple steps and/or multiple containers. Generally, these devices require collection of a fluid specimen in one device, isolation or segregation of the fluid specimen into an aliquot in the same device and transfer of the specimen to a different device for analysis. Separate collection, and testing requires an undesirable amount of handling of the specimen and is likely to lead to unacceptable levels of contamination.
There is a long felt need in the industry for a unitary device that performs collection, isolation and testing of a specimen that preserves the integrity of a portion of the specimen, isolates a separate portion of the specimen for testing, and minimizes the risk of misidentification. One of the difficulties in realizing such a device is that current federal regulations prohibit mixing the collected specimen with the aliquot specimen or the test specimen. Existing prior art devices that perform collection, isolation and testing have not adequately maintained separation between the collected fluid specimen, the aliquot and the test specimen. These devices have also failed to provide a totally sealed system in that bodily fluids leak to the outside environment. Furthermore, existing prior art devices have experienced undesirably high error rates in their function and in their test results.